PURPOSE OF JOB:

The Senior Director, Regulatory Affairs CMC is responsible for progressing our therapeutic candidates towards U.S. and global approvals. The Senior Director is a highly effective and collaborative leader, manager, and mentor, responsible for developing and executing innovative regulatory strategies in support of chemistry, manufacturing, and controls (CMC) development with cross-functional team members in support of RAPT's global development programs to treat patients with inflammatory and immunologic diseases. They will provide direction to senior management and cross-functional teams, work in close partnership with Regulatory/CMC/Quality leadership, to shape the overall manufacturing strategy and achieve development milestones in a timely and compliant manner. This role can be remote in the U.S. or at the South San Francisco location.

MAJOR DUTIES AND RESPONSIBILITIES:

Lead and manage all aspects of CMC regulatory strategy development (early- to late- stage/registration/post-market) Integrate CMC plans with overall development plans. Plan, coordinate, and communicate to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones Lead teams in examining regulatory strategy options, provide relevant regulatory guidance Provide regulatory leadership and guidance to senior management and cross-functional project teams, including external contractors, vendors, and consultants, to design and implement high quality regulatory strategies Identify and assess regulatory risks and critical-path activities associated with CMC development programs and work to identify regulatory strategies to mitigate risks Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs and understand the regulatory landscape Evaluate proposed manufacturing changes for global impact and provide strategic regulatory strategies that support compliant change implementation Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals Serve as the Regulatory point of contact for Contract Manufacturing Organizations and Qualified Persons Liaise directly with FDA, and other global regulatory health authorities, as appropriate Prepare and lead teams through successful regulatory meetings and interactions with global regulatory health authorities Lead global CMC regulatory submission development. Responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, NDA/MAA, pre-meeting briefing packages, etc.) Participate in the recruitment, performance, and management of staff in Regulatory Affairs, including coaching, career development and oversight of work, as required Lead assigned department initiatives and seek opportunities to foster interdepartmental collaboration Develop processes and infrastructure that support program needs, including but not limited to SOP development Build positive professional relationships and trust with team members, colleagues, external contractors, vendors, consultants, and regulatory authority contacts EDUCATION REQUIREMENTS: Bachelor's degree in science, engineering, or related discipline Advanced degree and/or Regulatory Affairs Certification (RAC) is a plus (e.g., PhD, MS in life science or MBA) EXPERIENCE REQUIREMENTS: 12 years Regulatory Affairs experience in the biopharmaceutical industry or equivalent Extensive knowledge of cGMP, CMC regulatory requirements for biologics and small molecules, and early- to late-stage experience with US, EU, international regulatory submissions in eCTD format. Expert knowledge of industry best practices and standards in Regulatory Affairs. A minimum of 5 years' managerial experience Ability to lead matrixed teams, drive and influence effective collaborations Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience Demonstrated successful track record of interacting with global regulatory health authorities (face-to-face and other formal interactions) and effectively moving products through the development process Experience with major submissions, including IND and BLA/NDA Ability to interact effectively across all levels of the organizations; meet priorities and deadlines in alignment with corporate goals and objectives Recognized as an influential leader who possesses a cross-functional collaborative skill set Demonstrated proficiency in planning for department resources Demonstrated ability to work both independently and in a team environment Highly responsible, self-motivated professional with enthusiasm and passion for the work Strong work ethic that with an appropriate sense of urgency and accuracy Entrepreneurial orientation with the ability to effectively operate in a dynamic environment Ability to problem-solve complex issues, often in a cross-functional team setting Prior experience managing direct reports, including coaching and career development Excellent organizational skills that enable the successful execution of multiple simultaneous projects Strong attention to detail and the ability to coordinate and oversee multiple activities